Switzerland is a Third Country for medical devicesMay 27, 2021
UK: Mid-risk Device Registration Deadline ApproachingAugust 2, 2021
Page Last Updated: 21 April 2023
Why is Europe ‘reinventing the wheel’ with EMDN? Why not use the already widely adopted GMDN system?
For many years, Global Medical Device Nomenclature (GMDN) codes were the de facto system for categorizing medical devices in Europe. The GMDN database is extensive and recognized by many international regulators, including European Competent Authorities for over a decade.
So — if use of the GMDN system is prevelant in Europe, and the MDR/IVDR requires a nomenclature system as part of its medical device database (EUDAMED), why isn’t Europe using GMDN codes?
The MDR/IVDR stress that the nomenclature system should be free of charge.
While the GMDN Agency does have a Basic membership level available for free, higher levels of membership require payment of an annual fee. The fee varies depending on the size and type of organization.
As a result, the Commission decided to develop its own European Medical Device Nomenclature (EMDN) system instead.
To facilitate the functioning of the European database on medical devices (‘EUDAMED’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature
-MDR Art. 26 & IVDR Art. 23
What does Classificazione Nazionale Dispositivi medici (CND) have to do with EMDN?
Since the EU Commission had to develop a new free-of-charge nomenclature system, this is where the CNDs come into the discussion.
CNDs are the Italian Ministry of Health’s medical device nomenclature: ‘Classificazione Nazionale Dispositivi medici’. The EU Commission decided to base its new EMDN system on CNDs, which were already in use by the Italian, Greek and Portuguese national competent authorities.
Why is a nomenclature system required at all?
…plays a key role in MDR/IVDR device documentation and technical documentation, sampling of technical documentation conducted by notified bodies, post-market surveillance, vigilance and post-market data analysis, etc.
It is intended to support all actors in their activities under the MDR/IVDR and provides key device descriptions to patients as regards their own devices and all other devices available on the market and registered in EUDAMED.
-EU Medical Device Coordination Group (MDCG) document 2021-12
Frequently Asked Questions
Which nomenclature is required in the EU, UK, Switzerland?
The following nomenclature systems are required for each market:
European Union: EMDN codes required when completing the device registration in EUDAMED*
Switzerland: EMDN codes required when completing the device registration in EUDAMED**
United Kingdom: GMDN codes required when completing the device registration in the MHRA’s system
*EUDAMED was originally scheduled to go live 26 May 2020. However, the EU Commission postponed EUDAMED’s release. The new date is Q2 2024 for all six modules to be released. In the meantime, various modules have been released for use on a voluntary basis, including the Actor registration module which allows economic operators, e.g., manufacturers, to obtain their Single Registration Number (SRN).
**The Mutual Recognition Agreement (MRA)
between Switzerland and the EU has lapsed for medical devices. As a result, Swissmedic no longer has access to EUDAMED, other than the publicly available version. However, the Swiss Federal Council has implemented the MDR & IVDR into its national law – including the mandatory use of EUDAMED.
The Swiss Federal Council is still hopeful to resolve the MRA issue in the future. In the meantime, Switzerland is in the process of developing its own EUDAMED-like registration database.
Click here to read: Swiss Medical Device Registration Requirements
Are EMDN/GMDN codes required on product labeling?
No. EMDN/GMDN codes are not required to be identified on the product labeling or instructions for use in Europe, the UK or Switzerland.
That said, EMDN/GMDN is required as part of the Unique Device Identification (UDI) system. As a result, the EMDN/GMDN will be contained within the UDI-DI information. The UDI carrier (e.g., barcode) is required on the device labeling, although a transition period has been granted for when the UDI carrier must appear on the labeling. Therefore, in roundabout way, the EMDN/GMDN will be on the labeling, but embedded as part of the UDI-DI.
MDR, Art. 123(f):
- For implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021
- For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023
- For class I devices Article 27(4) shall apply from 26 May 2025
MDR, Art. 123(g):
with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
(i) implantable devices and class III devices from 26 May 2023
(ii) class IIa and class IIb devices from 26 May 2025
(iii) class I devices from 26 May 2027
IVDR, Art. 113(e)
- For class D devices, Article 24(4) shall apply from 26 May 2023
- For class B and class C devices Article 24(4) shall apply from 26 May 2025
- For class A devices Article 24(4) shall apply from 26 May 2027
How are GMDN codes structured?
GMDNs have a five-digit numerical code, a Term Name and a Definition.
Below is an example provided by the GMDN Agency on their website:
GMDN Term Name:
Scalpel, single use
A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless-steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.
How are EMDN codes structured?
EMDN codes have up to 13 characters, plus an Official Term in Italian and a Draft Term in English.
The structure is made up of: Category + Group + Type + Type(s).
Does the above seem complicated?
A real life example helps clarify that the structure is actually straight-forward. Using a Single Use Scalpel as an example, it would appear as:
The breakdown for a single use scalpel is:
Level 1 (Category) = Various Medical Devices
Level 2 (Group) = Cutting Devices, Single-Use
Level 3 (Type) = Scalpels, Single-Use
Level 4 (Type) = Scalpels with safety systems, single-use or Scalpels without safety systems, single-use
NOTE: The 4th level is the ‘generic device group’ as defined in the MDR and the 3rd level is the ‘generic device group’ as defined in the IVDR. This is per EU guidance document MDCG 2019-13, which states that the “generic device group is to be understood, in respect to the MDR as the 4th level of the EMDN and in respect to the IVDR as the 3rd level of the EMDN in combination with the most appropriate IVP code.” So using the above device as an example, “Scalpels with safety systems, single use” or “Scalpels without safety systems, single use” would be the generic device group.
How do I find EMDN codes?
The EMDN database is located: HERE
Unlike the GMDN database, you may download the full Excel list of EMDN codes. However, note that that EMDN codes may be modified and/or added as needed, making a downloaded Excel or PDF list outdated over time.
Your EMDN code will be linked to the Unique Device Identifier – Device Identifier (UDI-DI) as part of the EUDAMED device registration process. As well, manufacturers should identify the EMDN code in its technical documentation file and procedures as applicable.
How do I find CND codes?
CND codes can be found on the Italian Competent Authority’s website: HERE
The list of CND codes is available in excel and PDF and is available for download.